BronchiolitisAbrystusNCT07251972
Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns
An observational study of Bronchiolitis, run by Jean-Michel HASCOET at 1 site in France.
Trial summary
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Read more about this study
- Who is it for?
- Ages 4 days to 8 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- to compare vaccine and monoclonal antibody
- Type of treatment
- Vaccines
- How many people
- 1,137 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 2 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 days to 8 months
- All sexes
- Child
Study population: term born neonate
Who may be able to join
- all term born neonates
Who cannot join
- postnatal transfert
- born at home or in birthing center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns in a Level 3 Maternity Unit During Winter 2025-2026
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed.
Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period.
Currently, no superiority or difference has been described for either immunoprophylaxis method.
- Conditions
- Bronchiolitis
- Being tested
- to compare vaccine and monoclonal antibody
- Keywords
- immunoprophylaxis RSV
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to compare vaccine and monoclonal antibodyBiological
collect the details at birth of chosen immunoprophylaxis and collect if later there will be any hospitalisation for bronchiolitis or consultation emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchiolitis incidence
Number of emergency room visits for bronchiolitis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2025
- Primary completion30 Apr 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Michel HASCOET
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251972
- Sponsor's protocol ID
- 2025PI033
- Acronym
- Abrystus
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns in a Level 3 Maternity Unit During Winter 2025-2026
- ClinicalTrials.gov ID
- NCT07251972
- Acronym / sponsor ID
- Abrystus / 2025PI033
- Conditions
- Bronchiolitis
- Keywords
- immunoprophylaxis RSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,137 participants (actual)
- Lead sponsor
- Jean-Michel HASCOETUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed.
Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period.
Currently, no superiority or difference has been described for either immunoprophylaxis method.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 days to 8 months
- Sex
- All
- Age groups
- Child
- Study population
- term born neonate
Key inclusion criteria (1 listed)
- all term born neonates
Key exclusion criteria (2 listed)
- postnatal transfert
- born at home or in birthing center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to compare vaccine and monoclonal antibodycollect the details at birth of chosen immunoprophylaxis and collect if later there will be any hospitalisation for bronchiolitis or consultation emergencies | Biological | – |
Primary outcome
Bronchiolitis incidence
Time frame: 8 months
Number of emergency room visits for bronchiolitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Jean-Michel HASCOET at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchiolitis incidence (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.